UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011525
Receipt No. R000013482
Scientific Title Identification of urinary biomarkers in diabetic nephropathy by glycan profiling
Date of disclosure of the study information 2013/08/20
Last modified on 2019/08/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Identification of urinary biomarkers in diabetic nephropathy by glycan profiling
Acronym U-CARE study (Urinary biomarker for continuous and rapid progression of diabetic nephropathy)
Scientific Title Identification of urinary biomarkers in diabetic nephropathy by glycan profiling
Scientific Title:Acronym U-CARE study (Urinary biomarker for continuous and rapid progression of diabetic nephropathy)
Region
Japan

Condition
Condition Diabetic nephropathy
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology Neurology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Identification of urinary biomarkers to predict the progression of diabetic nephropathy by lectin array analyses
Basic objectives2 Others
Basic objectives -Others To evaluate the predictive values of urinary markers identified by lectin array analyses
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Decline of estimated glomerular filtration rate (eGFR)
Key secondary outcomes Increase in albuminuria.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria The patients with type 1 and type diabetes.
Key exclusion criteria The patients with new onset of malignancies within 5 years. Liver cirrhosis.
Target sample size 800

Research contact person
Name of lead principal investigator
1st name Jun
Middle name
Last name Wada
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Medicine and Clinical Science
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL 086-235-7235
Email junwada@okayama-u.ac.jp

Public contact
Name of contact person
1st name Koki
Middle name
Last name Mise
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Medicine and Clinical Science
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL 0862357232
Homepage URL
Email kokims-frz@okayama-u.ac.jp

Sponsor
Institute Department of Nephrology, Rheumatology, Endocrinology and Metabolism, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Health Labor Sciences Research Grant, Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
Tel 086-235-6503
Email mae6605@adm.okayama-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 777
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2012 Year 06 Month 26 Day
Date of IRB
2012 Year 06 Month 26 Day
Anticipated trial start date
2012 Year 06 Month 26 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will perform the lectin array analyses to identify urinary markers to predict the progression of diabetic nephropathy, i.e. decline of eGFR and increase in albuminuria. We plan to measure the levels ofurinary markers by ELISA, such as Haptoglobin, Alpha-2-macroglobulin, Apolipoprotein A-I, Protein AMBP (alpha-1-microglobulin), Hemopexin, Ceruloplasmin, Alpha-1B-glycoprotein, Prostaglandin-H2 D-isomerase, Alpha-1-acid glycoprotein 1 (orosomucoid), Vitamin D-binding protein, N-acetylmuramoyl-L-alanine amidase, Alpha-2-HS-glycoprotein (Fetuin-A), Angiotensinogen, Kininogen-1, Complement C4-A, Plasma protease C1 inhibitor, Complement C3, Antithrombin-III, Prothrombin.

Management information
Registered date
2013 Year 08 Month 20 Day
Last modified on
2019 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013482

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.